Bengaluru: Biocon Limited on Monday said its wholly owned subsidiary, Biocon Pharma Limited, has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Everolimus Tablets for Oral Suspension.
According to the regulatory filing, the approval covers 2 mg, 3 mg and 5 mg strengths of Everolimus Tablets for Oral Suspension. The product is indicated for the treatment of adult and pediatric patients aged one year and above with Tuberous Sclerosis Complex (TSC) who have Subependymal Giant Cell Astrocytoma (SEGA).
In addition, the approved formulation is also indicated as an adjunctive treatment for adult and pediatric patients aged two years and older with TSC-associated partial-onset seizures, the company said in its notification to the exchanges .
Biocon stated that the latest USFDA approval will further strengthen its vertically integrated drug portfolio, reinforcing the company’s presence in the complex generics and specialty pharmaceutical segment in regulated markets.
